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NCT02421601 · ClinicalTrials.gov registry record · Phase 3

A Study of SI-6603 in Patients With Lumbar Disc Herniation

A Phase 3 study, sponsored by Seikagaku Corporation.

Completed
Registry status
Phase 3
Development phase
1,011
Enrollment target

NCT02421601: Completed Phase 3 study, sponsored by Seikagaku Corporation.

NCT02421601 is a Phase 3 study that has completed, run by Seikagaku Corporation. The registered enrollment target is 1,011 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02421601, a Phase 3 study, has completed, sponsored by Seikagaku Corporation.

COMPLETED
Registry status
Phase 3
Development phase
1,011 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

Primary Outcome

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that began or that worsened in severity after the investigational drug had been administered. All AEs, including intercurrent illnesses and regardless of the relationship to investigational drug, occurring during the study were documented from the signing of the informed consent form until completion of final visit. Concomitant illnesses, which existed before entry into the study, were not considered AEs unless they w

Interventions

  • DRUG Condoliase

Trial Details

FieldValue
Enrollment Target 1,011 participants
Start Date 2015-03
Est. Completion 2018-02
Phase Phase 3
Seikagaku Corporation

12 total trials

What the finished NCT02421601 record still lists

NCT02421601 is an interventional study that assigns participants to a tested intervention. Its 1,011 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher).

The record links to 0 conditions, and to 1 intervention - of which Condoliase is the first listed.

NCT02421601 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02421601 about?

NCT02421601 is a clinical study titled "A Study of SI-6603 in Patients With Lumbar Disc Herniation". The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

What is the current status of trial NCT02421601?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,011 participants. The study started on 2015-03. Estimated completion is 2018-02.

What interventions are being tested in trial NCT02421601?

The interventions under investigation include: Condoliase (DRUG).

Who is sponsoring clinical trial NCT02421601?

This trial is sponsored by Seikagaku Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02421601's enrollment target sits among peer trials

1,011 295th of 2000 higher than 1,706 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02421601, the US trial registry maintained by the National Library of Medicine. NCT02421601 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.